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Profile of Pain and Unpleasant Sensations in Patients With Referred Pain

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ClinicalTrials.gov Identifier: NCT03926364
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Aalborg University Hospital
Information provided by (Responsible Party):
Shellie A. Boudreau, Aalborg University

Brief Summary:

This feasibility study primarily aimed to assess the technology acceptance and usability of a pain tracking software in patients with spinally referred chronic pain. The secondary aim was to assess the fluctuations in pain intensity and distribution, using the pain tracking software during a 3-month period. Additionally, the study aimed to explore the patients' behavior when self-reporting pain when given the opportunity to use a variety of pain quality descriptors, such as tingling, burning and stabbing.

Patients with spinally referred chronic pain will be recruited to participate. Participants will be asked to use a pain tracking software to create weekly pain reports for a 3-month period. These pain reports consist of pain drawings and intensity scales. Additionally, patients will complete baseline disability and pain catastrophizing online questionnaires. The project does not affect treatment or does not offer any intervention.


Condition or disease Intervention/treatment
Referred Pain Somatic Pain Neuropathic Pain Other: Patients with referred pain

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spatiotemporal Profile of Pain and Unpleasant Sensations in Referred Pain: a Feasibility Study
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : July 31, 2019

Group/Cohort Intervention/treatment
Patients
Referred pain
Other: Patients with referred pain
The project does not affect treatment or does not offer any intervention.




Primary Outcome Measures :
  1. Change in pain extent for 3 months [ Time Frame: 3 months ]
    Changes in pain extent as measured by the number of pixels drawn in digital pain drawings, at weekly intervals.


Secondary Outcome Measures :
  1. Change in pain intensity for 3 months [ Time Frame: 3 months ]
    Changes in usual and current pain intensity as measured by a Numerical Rating Scale, at a weekly interval.

  2. Changes in pain location for 3 months [ Time Frame: 3 months ]
    Changes of the location of pain measured by appearance and disappearance of pain in different body regions.

  3. Disability levels at baseline [ Time Frame: Baseline ]
    Description of disability levels as assessed by the Oswestry (if pain located in back) or the Neck Disability Index (if pain located in neck) online questionnaires.

  4. Pain Catastrophizing score [ Time Frame: Baseline ]
    Scores obtained from an online Pain Catastrophizing Scale (PCS) at baseline


Other Outcome Measures:
  1. Demographic information [ Time Frame: At baseline ]
    Online demographic information



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with referred pain recruited from advertisement in public areas, social media, public and collaborating private clinics and hospitals.
Criteria

Inclusion Criteria:

  • Suffer from pain in the neck or lumbar spine referring to a limb for a more than 7 consecutive days
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • Pregnancy or breastfeeding, severe infections, cancer.
  • Epilepsy, Multiple sclerosis, history of stroke, diabetes, traumatic spinal cord injury resulting in permanent functions loss
  • Lack of ability to cooperate due to language barrier, cognition or inability to use technology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926364


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark, 9000
Aalborg University
Aalborg, Denmark, 9220
Sponsors and Collaborators
Aalborg University
Aalborg University Hospital
Investigators
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Principal Investigator: Shellie A Boudreau, PhD Associate Professor
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Responsible Party: Shellie A. Boudreau, Associate Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT03926364    
Other Study ID Numbers: 2015-57-0001/2
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The location of the advanced analyses may occur in collaboration with other machine learning experts

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shellie A. Boudreau, Aalborg University:
Pain drawings
referred pain
somatic pain
neuropathic pain
e-health
pain location
biopsychosocial factors
back pain
neck pain
pain extent
function
Additional relevant MeSH terms:
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Neuralgia
Pain, Referred
Nociceptive Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations